Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Komen print materials about genetic counseling and testing will be given to women.

Participants in this arm will receive the culturally tailored video either via a Youtube link or a DVD.

Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.

YouTube Video Arm

Vanessa Sheppard, PhD

Genetic counseling and testing (GCT) provides invaluable information for women who are at-risk of hereditary breast and/or ovarian cancer (HBOC). Black women underutilize GCT compared to White women. This study will conduct a RCT to test the efficacy of a culturally-tailored theory-based video intervention aimed to address key psychosocial factors (emotions, ambivalence) to improve uptake of genetic counseling in Black women at increased risk of HBOC. Findings from this study may offer an opportunity to engage at-risk Black women regarding genetic counseling through a multi-center trial and ultimately address the disparity in genetic counseling uptake that exists between Black and White women.

Breast cancer (BC) is the most frequently diagnosed cancer in African American women (hereafter referred to as "Black") and their cancer mortality is higher than other racial/ethnic groups in the United States (US). Compared to non-Hispanic Whites, Black women are diagnosed younger and with more advanced breast cancer. When diagnosed with BC, Black women present more often with triple-negative breast cancer (TNBC) an aggressive disease defined by the absence of estrogen and progesterone receptors, and human epidermal growth factor (HER)-2 expression. TNBC has been associated with pathogenic BRCA1 variants. Racial disparities also exist for women with ovarian cancer, the most lethal of the gynecologic cancers. Among women with advanced ovarian cancers up to 21% are associated with inherited pathogenic mutations the most common of which is BRCA1. Women who carry a pathogenic BRCA variant (PV) have a lifetime breast cancer risk of 55-70% and a lifetime ovarian cancer risk of up to 44%. The National Comprehensive Cancer Network (NCCN) recommends referral for Hereditary Breast and Ovarian Cancer (HBOC) genetic counseling and testing (GCT) for women at risk of carrying a BRCA PV. GCT provides women with information needed to make informed decisions to reduce their cancer risk, yet Black women are less likely to use GCT than whites. There is a dearth of interventions to address this issue and produced results are mixed and modest. Awareness of a positive result can inform treatment decisions for cancer patients and risk management in survivors or women unaffected with cancer.

Reasons for the lower uptake of GCT in Black women are multi-factorial and include access, knowledge, psycho-social factors, and may vary by cancer status (affected versus unaffected). There are substantial scientific gaps regarding effective interventions to address the sub-optimal uptake of GCT in Black women. To be effective, GCT interventions should be anchored within the needs and cultural values of their audience. While improving knowledge about GCT and one's individual risks is important, interventions that only address knowledge may not enhance uptake, as risk information evokes emotional reactions that are often stronger predictors of behaviors than cognitive factors.

Notably, this team has identified factors that contribute to Black women's uptake of GCT. In preliminary studies, researchers found that self-efficacy in making decisions about GCT and medical mistrust were associated with GCT uptake. Low knowledge among Black BC survivors at risk of HBOC has also been found. Anticipated negative emotions to GCT have been associated with lower uptake. Similar studies suggest that Black women report emotions related to fear of being singled out, and the fear of being hopeless. Because most interventions have focused solely on knowledge or access, the proposed study makes a considerable shift in the field by additionally targeting emotions, ambivalence, and developing a media-based risk communication tool.

Guided by two evidenced-based theories and preliminary data, this will be a two-phased mixed methods study. In Phase I (months 1-7), formative research and preliminary data will be used to develop the script for the GCT video. The script will be reviewed by GCT experts (n=4) and piloted in two focus groups (n=16) followed by a staged reading to make final refinements. In Phase II (months 8-24), a two-arm randomized trial (RCT) to compare GCT uptake and psycho-social outcomes between 50 at-risk Black women receiving printed Susan G. Komen developed GCT literature (control group) (n=25) or a tailored YouTube video intervention (n=25) will be conducted . All women will be referred to an appointment scheduler who will assist them with making an appointment with a genetic counselor. Participants will complete a baseline survey and follow-up assessment. The primary outcome will be genetic counseling uptake and receipt testing at 3-months will be explored. Specific aims are to:

Aim 1. Develop a YouTube video using a formative data for Black women at risk for HBOC.

Aim 2. Evaluate the efficacy of the intervention by comparing outcomes between women in the YouTube intervention arm vs. control group arm. H.2.1. Women in the intervention group (vs control group) will have higher genetic counseling uptake. H.2.2. Women in the intervention group (vs control group) will report higher knowledge, higher self-efficacy, higher endorsement of positive attitudes, and positive anticipated emotions about GCT. H.2.3. Most women (≥75%) will be satisfied with the experimental intervention.

Enhancing GCT in at-risk populations is a national priority. Given trends towards panel testing and other genomic advances, there is potential for existing disparities to widen. Findings will inform new strategies for behavioral interventions for Black women and a larger trial. If successful, the intervention could be easily disseminated broadening its reach to affected and unaffected women.

This study meets the Healthy People 2020 goals to enhance GRCA in at-risk populations, and the national priorities to increase diversity in genetics research participation and incorporate emotions into cancer research. Findings will inform new strategies for behavioral interventions targeting African-Americans in a larger trial.

Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video

There is no plan to make individual participant data available to other researchers.

Our primary outcome will be for participants to receive genetic testing and counseling. Investigators will be able to see if participant has scheduled a genetic testing appointment within the VCU Health appointment system.

The investigators will test general knowledge about hereditary breast and ovarian cancer

The investigators will test self-efficacy in genetic counseling services.

The investigators will test the emotional ambivalence about participating in genetic counseling services.

National Cancer Institute (NCI)

Virginia Commonwealth University

Patients in the enhanced education intervention arm will be scheduled for a redesigned therapy education session with a trained oncology nurse.

Patients in this arm will receive the usual care education provided to cancer patients undergoing systemic therapy, which includes information on treatment options, side effects, and support services without targeted genetic testing education.

In addition to the education conducted as part of usual care, the nurse will: 1) provide basic education on GCT; and 2) if the patient is eligible and agreeable to GCT, place a referral to GCT (if not already ordered).

Patients will also be provided with written materials reinforcing the key messages of GCT education, designed to be understandable to individuals without a medical background. Nurses will also conduct a follow-up "nudge" by sending an in basket message via electronic medical record to ensure that the referrals are processed by the referral coordinators.

Enhanced education

A brief introduction to GCT will be provided in accordance with the information covered in the "chemo education binder," which is the current standard of care at Enloe Regional Cancer Center. As per the usual care, referrals for genetic testing will be clinician-initiated without the proactive involvement of the RN.

Usual care education

Tiffany Capuano, RN, BSN, OCN

Ranjan Pathak, MD MHS

Genetic factors are a significant determinant of the likelihood of developing various types of cancers. Identification of germline risk can have important implications for both patients and their families. Although estimates vary, pathogenic germline variants can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Unfortunately, despite progress in multigene testing and the identification of heritable conditions, genetic counseling and testing (GCT) remains underutilized among cancer patients. Although there are multiple barriers to low testing, initial referral to GCT from the treating oncologist has been noted to be the most significant barrier.

Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types and improve the uptake of genomic testing in cancer patients. Despite proven benefits, community cancer centers often face resource limitations that prevent them from consistently assigning a dedicated nurse navigator to cancer patients. However, community centers universally have oncology nurses who routinely educate patients about their systemic therapies. By enhancing the "therapy education" sessions, the investigators hypothesize that oncology nurses can bridge this gap and potentially identify eligible patients, provide essential education on the importance of genetic testing, and facilitate the referral process. The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced education" intervention specifically designed to increase the uptake of GCT in adult cancer patients.

Identification of germline risk can have important implications for both patients and their families: it can help patients develop tailored cancer surveillance, risk-reducing measures, reproductive planning, identify novel genotype-directed drug targets, and also optimally address the risk of malignancy in at-risk relatives. Although estimates vary, pathogenic germline variants (PGV) can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Although national and international guidelines such as the National Comprehensive Cancer Network (NCCN) outline the criteria for who should be offered genetic counseling and testing (GCT) based on a patient's personal and/or family history, recent studies have found that broader testing of at-risk patients might help identify PGV in patients who otherwise would not have met guidelines for genetic testing.

Unfortunately, despite progress in multigene testing and the identification of heritable conditions, GCT remains underutilized among cancer patients. A recent study revealed that the uptake of germline testing among cancer patients remains strikingly low; in California and Georgia, between 2013 and 2019, less than 7% of patients diagnosed with cancer underwent such testing. While a study indicates a promising recent increase in the use of germline testing among women diagnosed with breast and ovarian cancer from 2012 to 2019, there is still a significant gap in ensuring that all eligible patients are provided with GCT. Although there are multiple barriers to low testing, initial referral to GCT from the treating oncologist has been noted to be the most significant barrier.

Community cancer centers are crucial in providing accessible care to a large segment of the cancer patient population. However, community cancer centers often face various challenges with limited resources for specialized genetic services variability in community oncologists' practice patterns and perceptions in GCT, and potentially urban-rural variability in patient awareness and understanding of the potential impact of genetic testing on their care.

Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types, in addition to improving the uptake of genomic testing in cancer patients. Despite proven benefits, community cancer centers often face resource limitations that prevent them from consistently assigning a dedicated nurse navigator to cancer patients. However, community centers universally have oncology nurses who routinely educate patients about their systemic therapies. By enhancing the "therapy education" sessions, the investigators hypothesize that oncology nurses can bridge this gap and potentially identify eligible patients, provide essential education on the importance of genetic testing, and facilitate the referral process. This approach leverages the trust and communication between nurses and patients and the principle that informed patients are more likely to engage in their healthcare decisions to potentially overcome barriers to genetic testing uptake.

The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced education" intervention specifically designed to increase the uptake of GCT in adult cancer patients. Patients in the enhanced education arm will be scheduled for an enhanced therapy education session with a trained oncology nurse for patients starting or switching their systemic therapies. In addition to the education conducted as part of the usual care, the nurse will: 1) provide detailed education on GCT; and 2) if the patient is eligible and agreeable to GCT, order a referral to GCT (if not already ordered). Nurses will provide a "nudge" to the referral coordinators within a week of the education session to ensure the referral process is completed.

This pilot study will randomize patients who are starting or switching their systemic therapies for solid cancers, eligible for GCT, and have not undergone prior genetic testing into two groups: "enhanced education intervention" and "usual care education".

A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention

Genetic Testing Uptake Through an Enhanced Oncology Nurse-Led Intervention in Patients With Solid Tumors (GENESIS): A Pilot Study

Recruitment rates (percentage of participants who agree to participate out of those approached), completion rate of follow-up assessments (percentage of patients that complete follow-up assessment), and retention rates (percentage of patients retained in the study throughout the study period).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Improving Uptake of Genetic Cancer Risk Assessment in African American Women- Video	NCT04476654	Breast Cancer	YouTube Video A...	18 Years - 100 Years	Virginia Commonwealth University
A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention	NCT06436157	Solid Tumor, Ad...	Enhanced educat... Usual care educ...	18 Years -	Enloe Health

Spots Global Cancer Trial Database for genetic counseling and testing